Factors Associated with Nonhome Discharge After Endovascular Aneurysm Repair.

OBJECTIVE: This study aims to identify preoperative factors associated with non-home discharge (NHD) after endovascular aneurysm repair (EVAR). NHD has implications for patient care, readmission, and long-term mortality; nevertheless, existing literature lacks information regarding factors associated with NHD for patients undergoing EVAR. In contrast, our study assesses preoperative factors associated with NHD for this population by utilizing national data from the Vascular Quality Initiative (VQI). METHODS: We identified adult patients who underwent elective EVAR in the VQI (2003-2022) and excluded those who were not living at home preoperatively. Multivariable logistic regression was used to identify preoperative factors associated with NHD. Kaplan-Meier methods and Cox-regression analyses were used to assess the impact of NHD on 5-year survival as a secondary outcome. RESULTS: 61,792 patients were included, of which 3,155 (5.1%) had NHD. NHD patients were more likely to be older (79 [73-18] years vs. 73[67-79] years), female (33.7% vs. 18.2%; P<.001), non-white (16.0% vs. 11.7%; P<.001) and have more comorbidities. NHD patients had higher rates of postoperative complications (acute kidney injury: 11.9% vs. 2.0%; P<.001, myocardial infarction: 3.8% vs. 0.5%; P<.001, and in-hospital reintervention: 4.7% vs. 0.5%; P=.033). Multivariable analysis revealed many preoperative characteristics were associated with higher odds of NHD: most notably, age (per additional decade: OR=2.15, 95% CI:2.03-2.28; P<.001), female sex (OR=1.79, 95% CI:1.63-1.95; P<.001) and aneurysm diameter >65mm (OR=2.18, 95% CI:1.98-2.39; P<.001), along with potentially modifiable factors including: anemia, COPD, CHF, weight, and diabetes. In contrast, aspirin, statin, and ACE-inhibitor/ARB usage were associated with lower odds of NHD. NHD was associated with higher hazards of 5-year mortality, even after adjusting for confounders (40% vs. 14%, aHR=2.13, 95% CI:1.86-2.44; P<.001). CONCLUSIONS: Several factors were associated with higher odds of NHD following elective EVAR, including non-modifiable factors such as female sex and larger aortic diameter, and potentially modifiable factors such as anemia, COPD, CHF, BMI, and diabetes. Special attention should be given to populations with non-modifiable factors, and efforts at optimizing medical conditions with higher NHD likelihood seems appropriate to improve patient outcomes and quality of life after EVAR.

Ten years of physician-modified endografts.

OBJECTIVES: Physician-modified endografts (PMEGs) have expanded the scope of endovascular abdominal aortic repair beyond the infrarenal aorta. Patients with prohibitively high surgical risk and visceral segment disease are often candidates for this intervention, which mitigates much of the morbidity and mortality associated with conventional open repair. Here we present the institutional PMEG experience of a high-volume aortic center. METHODS: We studied all PMEGs performed at our institution from 2012 to 2023. We included cases that were submitted to the US Food sand Drug Administration in support of an investigational device exemption (IDE) trial, as well as those in the subsequently approved IDE trial. Over this 11-year period, we assessed the changes in operative characteristics and perioperative outcomes over time. Additionally, we compared the outcomes from PMEG cases to those of Zenith fenestrated (ZFEN) grafts (done by the surgeon with the PMEG IDE), an alternative device used for aneurysms involving the lower visceral segment. Here we assessed operative characteristics, perioperative outcomes, and 5-year survival and reintervention rates. RESULTS: When assessing the change over time for PMEG operative characteristics, we found a trend toward decreased fluoroscopy time and decreased proportions of completion type I and type III endoleaks (all P < .05). Perioperative outcomes have remained stable over this period, with an overall perioperative mortality rate of 4.9% (noting that this registry also includes cases that were urgent and emergent). Despite the increased complexity of PMEGs relative to ZFENs, we found comparable perioperative outcomes with regard to mortality (4.9% vs 4.3%; P = .86), permanent spinal cord ischemia (1.1% vs 0%; P = .38), postoperative myocardial infarction (4.3% vs 2.9%; P = .60), postoperative respiratory failure (7.1% vs 4.3%; P = .43), and new dialysis use (2.2% vs 4.3%; P = .35). Additionally, 5-year survival (PMEG 54% vs ZFEN 65%; P = .15) and freedom from reintervention (63% vs 74%; P = .07) were similar between these cohorts. CONCLUSIONS: Throughout our >10-year experience with PMEGs, we have noted improvements in operative outcomes, which can likely be attributed to technological advances and increased physician experience. Additionally, we have found that PMEGs perform well when compared with ZFENs, despite being a more complicated repair that is able to treat a larger segment of the aorta. PMEGs are crucial for the comprehensive care of vascular patients with complex aortic disease. As further operative advancements are made, we only expect the use of this intervention to increase.

Early postoperative COVID infection is associated with significantly increased risk of venous thromboembolism after metabolic and bariatric surgery.

BACKGROUND: Patients who undergo metabolic and bariatric surgery (MBS) are at risk for thromboembolism. Patients are susceptible to coronavirus throughout the perioperative period, which also has a well-known association with thrombotic complications. OBJECTIVES: To identify and define the association between venous thromboembolism (VTE) and postoperative coronavirus diagnosis in bariatric surgery patients. SETTING: United States. METHODS: We conducted a retrospective cohort study using the MBS Accreditation and Quality Improvement Program (MBSAQIP) 2021 database to analyze the incidence of VTE within 30 days of surgery. VTE was a composite variable defined as either postoperative pulmonary embolism or postoperative venous thrombus requiring treatment. Cohorts were stratified by whether the patient was diagnosed with postoperative coronavirus. We created a multivariable logistic regression model to determine the adjusted odds of postoperative VTE based on various factors. Additionally, we conducted subset analyses of sleeve gastrectomy and Roux-en-Y bypass cases, the 2 most frequent bariatric operations in the United States. RESULTS: Patients diagnosed with postoperative coronavirus were significantly more likely to develop postoperative VTE (1.1% versus .3%, P < .001). In our logistic regression model, the adjusted odds of postoperative VTE for patients with postoperative coronavirus was 3.55 (95% CI: 2.15-5.87, P < .001). For patients who underwent Roux-en-Y bypass, the adjusted odds was even greater at 5.69 (95% CI: 2.76-11.70, P < .001). CONCLUSIONS: Early postoperative coronavirus infection after MBS is associated with higher odds of postoperative VTE. This persisted on subset analyses of the 2 most common procedures and appeared particularly important for Roux-en-Y bypass. COVID infection after MBS may warrant prolonged VTE prophylaxis.

Learning curve of transfemoral carotid artery stenting in the Vascular Quality Initiative registry.

OBJECTIVE: With the recent expansion of the Centers for Medicare and Medicaid Services coverage, transfemoral carotid artery stenting (tfCAS) is expected to play a larger role in the management of carotid disease. Existing research on the tfCAS learning curve, primarily conducted over a decade ago, may not adequately describe the current effect of physician experience on outcomes. Because approximately 30% of perioperative strokes/deaths post-CAS occur after discharge, appropriate thresholds for in-hospital event rates have been suggested to be <4% for symptomatic and <2% for asymptomatic patients. This study evaluates the tfCAS learning curve using Vascular Quality Initiative (VQI) data. METHODS: We identified VQI patients who underwent tfCAS between 2005 and 2023. Each physician's procedures were chronologically grouped into 12 categories, from procedure counts 1-25 to 351+. The primary outcome was in-hospital stroke/death rate; secondary outcomes were in-hospital stroke/death/myocardial infarction (MI), 30-day mortality, in-hospital stroke/transient ischemic attack (stroke/TIA), and access site complications. The relationship between outcomes and procedure counts was analyzed using the Cochran-Armitage test and a generalized linear model with restricted cubic splines. Our results were then validated using a generalized estimating equations model to account for the variability between physicians. RESULTS: We analyzed 43,147 procedures by 2476 physicians. In symptomatic patients, there was a decrease in rates of in-hospital stroke/death (procedure counts 1-25 to 351+: 5.2%-1.7%), in-hospital stroke/death/MI (5.8%-1.7%), 30-day mortality (4.6%-2.8%), in-hospital stroke/TIA (5.0%-1.1%), and access site complications (4.1%-1.1%) as physician experience increased (all P values < .05). The in-hospital stroke/death rate remained above 4% until 235 procedures. Similarly, in asymptomatic patients, there was a decrease in rates of in-hospital stroke/death (2.1%-1.6%), in-hospital stroke/death/MI (2.6%-1.6%), 30-day mortality (1.7%-0.4%), and in-hospital stroke/TIA (2.8%-1.6%) with increasing physician experience (all P values <.05). The in-hospital stroke/death rate remained above 2% until 13 procedures. CONCLUSIONS: In-hospital stroke/death and 30-day mortality rates after tfCAS decreased with increasing physician experience, showing a lengthy learning curve consistent with previous reports. Given that physicians' early cases may not be included in the VQI, the learning curve was likely underestimated. Nevertheless, a substantially high rate of in-hospital stroke/death was found in physicians' first 25 procedures. With the recent Centers for Medicare and Medicaid Services coverage expansion for tfCAS, a significant number of physicians would enter the early stage of the learning curve, potentially leading to increased postoperative complications.

Reinterventions and sac dynamics after fenestrated endovascular aortic repair with physician-modified endografts for index aneurysm repair and following proximal failure of prior endovascular aortic repair.

OBJECTIVE: The high frequency of reinterventions after fenestrated endovascular aortic repair (FEVAR) with physician-modified endografts (PMEGs) has been well-studied. However, the impact of prior EVAR on reinterventions and sac behavior following these procedures remains unknown. We analyzed 3-year rates of reinterventions and sac dynamics following PMEG for index aneurysm repair compared with PMEG for prior EVAR with loss of proximal seal. METHODS: We performed a retrospective analysis of 122 consecutive FEVARs with PMEGs at a tertiary care center submitted to the United States Food and Drug Administration in support of an investigational device exemption trial. We excluded patients with aortic dissection (n = 5), type I to III thoracoabdominal aneurysms (n = 13), non-elective procedures (n = 4), and prior aortic surgery other than EVAR (n = 8), for a final cohort of 92 patients. Patients were divided into those who underwent PMEG for index aneurysm repair (primary FEVAR) and those who underwent PMEG for rescue of prior EVAR with loss of proximal seal (secondary FEVAR). The primary outcomes were freedom from reintervention and sac dynamics (regression as ≥5 mm decrease, expansion as ≥5 mm increase, and stability as <5 mm increase or decrease) at 3 years. Secondary outcomes were perioperative mortality and 3-year survival. RESULTS: Of the 92 patients included, 56 (61%) underwent primary FEVAR and 36 (39%) underwent secondary FEVAR. Secondary FEVAR patients were older (78 years [interquartile range (IQR), 74.5-83.5 years] vs 73 years [IQR, 69-78.5 years]; P < .001), more frequently male (86% vs 68%; P = .048), and had larger aneurysms (72.5 mm [IQR, 65.5-81 mm] vs 59 mm [IQR, 55-65 mm]; P < .001). Perioperative mortality was 1.8% for primary FEVAR and 2.7% for secondary FEVAR (P = .75). At 3 years, overall survival was 84% for primary FEVAR and 71% for secondary FEVAR (P = .086). Freedom-from reintervention was significantly higher for primary FEVAR than secondary FEVAR, specifically 82% vs 38% at 3 years (P < .001). Primary FEVAR also had more desirable sac dynamics relative to secondary FEVAR at 3 years (primary: 54% stable, 46% regressed, 0% expanded vs secondary: 33% stable, 28% regressed, and 39% expanded; P = .038). CONCLUSIONS: FEVAR for primary aortic repair and FEVAR for rescue of prior EVAR with loss of proximal seal are two distinct entities. Following primary FEVAR, less than a quarter of patients have undergone reintervention at 3 years, and sac expansion was not seen in our cohort. Comparatively, 3 years after secondary FEVAR, over one-half of patients have undergone reintervention and over one-third have had ongoing sac expansion. Vigilant surveillance and a low threshold for further interventions are crucial following secondary FEVAR.

The effect of Fiber Optic RealShape technology on the reduction of radiation during complex endovascular surgery.

OBJECTIVE: Despite the advantages that fenestrated endovascular aortic repair has over open repair, it is accompanied by the consequence of radiation exposure, which can result in long-term complications for both the patient and surgical staff. Fiber Optic RealShape (FORS) technology is a novel advancement that uses emitted light from a fiber optic wire and enables the surgeon to cannulate vessels in real time without live fluoroscopy. This technology has been implemented at select centers to study its effectiveness for cannulation of target vessels and its impact on procedural radiation. METHODS: We collected prospective data on physician-modified endograft (PMEG) cases before and after the introduction of FORS technology. FORS PMEGs were matched with up to three conventional fluoroscopy cases by number of target vessels, inclusion of a bifurcated device below, aneurysm extent, and patient body mass index. The procedural radiation parameters were compared between these cohorts. Within the FORS cohort, we analyzed the rate of successful target vessel cannulation for all cases done with this technology (including cases other than PMEGs), and we compared the radiation between the cannulations using only FORS with those that abandoned FORS for conventional fluoroscopy. RESULTS: Nineteen FORS PMEGs were able to be matched to 45 conventional fluoroscopy cases. Procedures that used FORS technology had significantly reduced total air kerma (527 mGy vs 964 mGy), dose area product (121 Gy∗cm2 vs 186 Gy∗cm2), fluoroscopy dose (72.1 Gy∗cm2 vs 132.5 Gy∗cm2), and fluoroscopy time (45 minutes vs 72 minutes). There was no difference in procedure length, total contrast, or digital subtraction angiography. Within FORS cases, 66% of cannulations were completed using only FORS. Cannulations using only FORS had significant reduction of navigation air kerma (5.0 mGy vs 26.5 mGy), dose area product (1.2 Gy∗cm2 vs 5.1 Gy∗cm2), and fluoroscopy time (0.6 minutes vs 2.3 minutes) compared with cannulations abandoning FORS for conventional fluoroscopy. CONCLUSIONS: This study demonstrates the advantages of FORS for total procedural radiation as well as during individual cannulation tasks. The implementation of FORS for target vessel catheterization has the potential to decrease the total degree of radiation exposure for the patient and surgical staff during complex endovascular aortic surgeries.

Impact of Physician Experience on Stroke or Death Rates in Transfemoral Carotid Artery Stenting: Insights from the Vascular Quality Initiative.

Objective: With the recent expansion of the Centers for Medicare and Medicaid Services (CMS) coverage, transfemoral carotid artery stenting (tfCAS) is expected to play a larger role in the management of carotid disease. Existing research on the tfCAS learning curve, primarily conducted over a decade ago, may not adequately describe the current effect of physician experience on outcomes. This study evaluates the tfCAS learning curve using VQI data. Methods: We analyzed tfCAS patient data from 2005-2023. Each physician's procedures were chronologically grouped into 12 categories, from procedure counts 1-25 to 351+. Primary outcome was in-hospital stroke/death rate; secondary outcomes were in-hospital stroke/death/MI, 30-day mortality, and in-hospital stroke/TIA. The relationship between outcomes and procedure counts was analyzed using Cochran Armitage test and a generalized linear model with restricted cubic splines, validated using generalized estimating equations. Results: We analyzed 43,147 procedures by 2,476 physicians. In symptomatic patients, there was a decrease in rates of in-hospital stroke/death (procedure counts 1-25 to 351+: 5.2% to 1.7%), in-hospital stroke/death/MI (5.8% to 1.7%), 30-day mortality (4.6% to 2.8%), in-hospital stroke/TIA (5.0% to 1.1%) (all p-values<0.05). The in-hospital stroke/death rate remained above 4% until 235 procedures. Similarly, in asymptomatic patients, there was a decrease in rates of in-hospital stroke/death (2.1% to 1.6%), in-hospital stroke/death/MI (2.6% to 1.6%), 30-day mortality (1.7% to 0.4%), and in-hospital stroke/TIA (2.8% to 1.6%) with increasing physician experience (all p-values<0.05). The in-hospital stroke/death rate remained above 2% until 13 procedures. Conclusions: In-hospital stroke/death and 30-day mortality rates post-tfCAS decreased with increasing physician experience, showing a lengthy learning curve consistent with previous reports. Given that physicians' early cases may not be included in the VQI, the learning curve was likely underestimated. With the recent CMS coverage expansion for tfCAS, a significant number of physicians would enter the early stage of the learning curve, potentially leading to increased post-operative complications.